The following data is part of a premarket notification filed by Genzyme Biosurgery with the FDA for S-1150 Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.
| Device ID | K031554 |
| 510k Number | K031554 |
| Device Name: | S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Denise Lima |
| Correspondent | Denise Lima GENZYME BIOSURGERY 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-07-25 |
| Summary: | summary |